The following data is part of a premarket notification filed by Spectrum Spine, Llc with the FDA for Expandable Titanium Plif/tlif System.
| Device ID | K201024 |
| 510k Number | K201024 |
| Device Name: | Expandable Titanium PLIF/TLIF System |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | Spectrum Spine, LLC 4020 Stovall Terrace NE Atlanta, GA 30342 |
| Contact | James Robinson |
| Correspondent | Nathan Wright Empirical Testing Corp. 4628 Northpark Drive Colorado Springs, CO 80918 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-04-20 |
| Decision Date | 2021-04-29 |